A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)
NCT ID: NCT01163747
Last Updated: 2012-12-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
91 participants
INTERVENTIONAL
2010-09-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Methotrexate
Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
tocilizumab
Intravenous repeating dose
methotrexate
A stable dose of between 7.5 and 25 mg/week, oral or parenteral.
23-Valent Pneumococcal Polysaccharide Vaccine
Intramuscular or subcutaneous injection
Tetanus Toxoid Adsorbed Vaccine
Intramuscular injection
Tocilizumab + Methotrexate
Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
tocilizumab
Intravenous repeating dose
methotrexate
A stable dose of between 7.5 and 25 mg/week, oral or parenteral.
23-Valent Pneumococcal Polysaccharide Vaccine
Intramuscular or subcutaneous injection
Tetanus Toxoid Adsorbed Vaccine
Intramuscular injection
Interventions
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tocilizumab
Intravenous repeating dose
methotrexate
A stable dose of between 7.5 and 25 mg/week, oral or parenteral.
23-Valent Pneumococcal Polysaccharide Vaccine
Intramuscular or subcutaneous injection
Tetanus Toxoid Adsorbed Vaccine
Intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rheumatoid Arthritis (RA) of \> 6 months duration at baseline (American College of Rheumatology criteria)
* Willing to receive immunization with pneumococcal polysaccharide and tetanus toxoid adsorbed vaccines
* Previous immunization with pneumococcal polysaccharide must have occurred ≥ 3 years of baseline, with tetanus containing vaccine ≥ 5 years
* Methotrexate therapy for at least 8 weeks prior to baseline at stable dose of 7.5-25 mg/week (oral or parenteral)
* Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before baseline
* Oral corticosteroids must be at stable dose of \< 10 mg/day prednisone or equivalent
* Body weight ≤ 150 kg at screening
Exclusion Criteria
* History of or current inflammatory joint disease or rheumatic autoimmune disease other than RA
* Pre-existing central nervous system demyelinating or seizure disorders
* Active current or history of recurrent bacterial, viral fungal, mycobacterial and other infections
* Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to baseline or oral antibiotics within 2 weeks prior to baseline
* Active tuberculosis requiring treatment within 3 years prior to baseline
* Primary or secondary immunodeficiency (history or currently active)
* Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
* Previous treatment with RoActemra/Actemra
18 Years
64 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Micki Klearman, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Anniston, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Glendale, Arizona, United States
Mesa, Arizona, United States
Paradise Valley, Arizona, United States
Paradise Valley, Arizona, United States
Scottsdale, Arizona, United States
Jonesboro, Arkansas, United States
Fullerton, California, United States
Hemet, California, United States
San Leandro, California, United States
Santa Maria, California, United States
Upland, California, United States
Bridgeport, Connecticut, United States
Melbourne, Florida, United States
South Miami, Florida, United States
Tavares, Florida, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Maywood, Illinois, United States
Vernon Hills, Illinois, United States
South Bend, Indiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Saint Clair Shores, Michigan, United States
Tupelo, Mississippi, United States
Las Vegas, Nevada, United States
Manalapan, New Jersey, United States
Albany, New York, United States
Belmont, North Carolina, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Cleveland, Ohio, United States
Gallipolis, Ohio, United States
Middleburg Heights, Ohio, United States
Lake Oswego, Oregon, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wexford, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Charleston, South Carolina, United States
Orangeburg, South Carolina, United States
Dallas, Texas, United States
Mesquite, Texas, United States
Tacoma, Washington, United States
Clarksburg, West Virginia, United States
Countries
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References
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Bingham CO 3rd, Rizzo W, Kivitz A, Hassanali A, Upmanyu R, Klearman M. Humoral immune response to vaccines in patients with rheumatoid arthritis treated with tocilizumab: results of a randomised controlled trial (VISARA). Ann Rheum Dis. 2015 May;74(5):818-22. doi: 10.1136/annrheumdis-2013-204427. Epub 2014 Jan 21.
Other Identifiers
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NA25256
Identifier Type: -
Identifier Source: org_study_id